About Remimazolam

Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III trials. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary. During clinical studies, remimazolam demonstrated efficacy and safety with around 2,400 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.

PAION has completed clinical development of remimazolam for procedural sedation in the U.S. The U.S. licensee Cosmo plans to file for market approval in procedural sedation shortly and is responsible for any further development activities in the U.S. In Japan, remimazolam licensee Mundipharma filed for market approval in general anesthesia in December 2018 and in China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. In Europe, PAION initiated a Phase III study in general anesthesia in July 2018, for which patient recruitment is expected to be completed by the end of 2019.

In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation (beyond 24 hours) is another possible attractive indication for further development in the EU by PAION as well as by its licensees.

Remimazolam is partnered in the U.S. (Cosmo Pharmaceuticals), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS (R-Pharm), Turkey and the MENA region (TR-Pharm) and South Korea (Hana Pharm). For all other markets outside the EU, remimazolam is available for licensing.

 

More information at Sedation & anesthesia market.